Current management of patients with SLE is usually stratified by the degree of internal organ involvement; treatment strategies include a variety of immunosuppressive medications, used alone or in combination, that are limited both in their efficacy and by significant potential toxicities. There is an unmet need for improved treatment of inflammation in this patient population. The all-cause mortality in SLE has greatly improved but there is significant morbidity and increased mortality due to accelerated atherosclerotic vascular disease. Further, premature cardiovascular disease risk may be as high as 50-fold when compared to matched controls and is not explained by the traditional risk factors. The underlying pathogenic mechanisms involved in endothelial dysfunction leading to premature atherosclerosis in lupus remain elusive. Advances in immunosuppression and close monitoring of patients have decreased organ damage in lupus, but no drug to this date has proven to abrogate atherosclerosis development in SLE. Identifying a drug that has immunomodulatory effects and is also vasculo-protective is an unmet need in this disease.

The Lupus Clinical Research Program at NIAMS conducts innovative translational and clinical research into the causes, treatment, and prevention of SLE. The Lupus Clinical Research Program maintains a comprehensive clinical database of SLE patients that includes patient demographics, SLE disease activity and damage indices, patient-reported outcome tools, and other data for phenotyping our cohort. The SLE Natural History and Pathogenesis protocol serves as a pivotal resource for understanding and characterizing the heterogeneity of this disease, providing biological specimens and outstanding clinical phenotyping to various intramural and extramural labs involved in lupus research. This collaborative research model has led to several biomarker discoveries and scientific hypothesis generation. These discoveries have been translated into clinical trials by the Lupus Clinical Trials Unit.

The Lupus Clinical Trials Unit (LCTU) of the Lupus Clinical Research Program develops and implements clinical research protocols and conducts high impact, innovative clinical research based largely on the discoveries resulting from NIAMS IRP translational research.

Current Projects

• Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic Studies.
• The Role of PPAR-gamma Agonists in immunomodulation and Vascular Prevention in SLE (PPAR-SLE).
• Natural history of vascular damage and atherosclerosis development in SLE.
• Deep immuno-phenotyping and systematic study of serum proteins and gene expression in SLE.
• Aerobic Exercise in Women with Systemic Lupus Erythematosus (Exercise SLE).
• Genomic Effects of Glucocorticoids in Patients with Systemic Lupus Erythematosus.

Quality Improvement

Quality improvement (QI) is a framework used in health care to improve patient care, outcomes, and the development of health care professionals. It has been shown to improve morbidity and mortality. The LCTU has implemented several QI projects for our patient cohort.

• A health maintenance section has been incorporated into all progress notes to touch on areas affected by SLE and the drugs that treat this disease. 
• Patients with lupus are at a higher risk of osteoporosis because of chronic inflammation and the adverse effects of therapeutic medications, including glucocorticoids. We are working together with an interdisciplinary team to implement a standardized template for outpatient visits that incorporates osteoporosis assessment and management guidelines.
• A specific sun protection brochure was created and provided to patients as education regarding SLE and photosensitivity.
• Reproductive health is an important topic and should be a shared decision-making process between SLE patients and providers. We are currently working on implementing reproductive health counseling during patient visits.
• Patient-reported outcome surveys are completed at every visit to help clinicians better understand the patient's perceived health status and empower the patient in their health care process.

For more information, please contact Jun Chu (Jun.Chu2@nih.gov).

DC Lupus Consortium

In 2016, The Lupus Clinical Research Program established The DC Lupus Consortium (DCLC), a collaborative network of rheumatologists, nephrologists, physiatrists, and other health care providers interested in lupus clinical research in the Metropolitan DC area. The purpose of the DCLC is to promote partnerships and referrals to the NIAMS Lupus Clinical Research Program and collaborations with local and regional clinicians caring for patients with lupus.

NIH scientists, researchers, patient advocacy groups, and physicians both within and outside of NIH are welcome to join. To learn more about upcoming DCLC events, please contact Elaine Poncio (elaine.poncio@nih.gov) or Isabel Ochoa (ochoai@mail.nih.gov) to be added to the mailing list.

DCLC 2019

For over 25 years, the NIH has yielded a vast wealth of knowledge about this disease and made great strides in lupus clinical research. To recognize the accomplishments and milestones, a special 25th-anniversary event at the fourth annual meeting of the DCLC featured perspectives from research participants and presentations of current and future lupus research activities at the NIH.

Join Us for the Next DCLC

NIH scientists, researchers, patient advocacy groups, and physicians both within and outside of NIH are welcome to join this consortium. If you would like to learn more about upcoming DCLC events, please contact Elaine Poncio (elaine.poncio@nih.gov) or Isabel Ochoa (ochoai@mail.nih.gov) to be added to the mailing list.